Tirzepatide compounding wind-down ends for 503B facilities as FDA deadline passes

The Food and Drug Administration's 90-day wind-down period for 503B outsourcing facilities compounding copies of tirzepatide closed on March 19, 2025. State-licensed pharmacies and physicians compounding under section 503A lost the same protection on February 18, 2025 ^[1].

Both deadlines came from a December 19, 2024 FDA declaratory order finding that the tirzepatide injection shortage was resolved. That order revoked and replaced the agency's October 2, 2024 decision on the same question, which had been sent back to FDA for review after the Outsourcing Facilities Association and a compounding pharmacy sued over the removal ^[1]. Tirzepatide injection products were first added to the shortage list on December 15, 2022 ^[1].

FDA based the December decision on data from Eli Lilly and Company, the maker of Mounjaro and Zepbound, covering production, inventory, projected demand and wholesaler stock. The agency concluded that Lilly's supply "is currently meeting or exceeding demand" and would meet or exceed projected demand ^[1]. Mounjaro and Zepbound are the only FDA-approved tirzepatide products ^[1].

On March 5, 2025, a federal district court denied the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:24-cv-00953 (N.D. Tex.), leaving March 19, 2025 as the end of the 503B period ^[2].

The shortage listing mattered because outsourcing facilities may compound a drug from bulk drug substances only if the substance appears on the 503B bulks list or the compounded drug is on FDA's drug shortage list at the time of compounding, distribution and dispensing ^[2]. Tirzepatide appears on neither list ^[2].

FDA has acknowledged that patients and prescribers may still see intermittent, localized supply disruptions as products move from manufacturers and distributors to local pharmacies ^[1]. The agency said it received reports that some patients and pharmacists could not obtain the approved drugs and that a substantial amount of tirzepatide compounding was occurring, but it found that information had "important limitations" and did not outweigh Lilly's data ^[1]. FDA said it will keep monitoring supply and demand and could add tirzepatide back to the shortage list ^[1].

Even before the deadlines, 503A pharmacies could still compound tirzepatide under a narrow set of circumstances, such as documentation of medical necessity, but not as an "essentially a copy" of a commercially available product ^[3]. The law firm Frier Levitt, which advises compounders, wrote that 503B facilities will not be able to compound tirzepatide because it must be on the shortage list or the 503B bulks list ^[3]. FDA has said it may still act on other statutory or regulatory violations, such as findings that a product is substandard or unsafe ^[2].

Why it matters for patients

For people who have been filling prescriptions for compounded tirzepatide, the change means one supply route is now outside the exemption that allowed it. Compounded drugs are not FDA-approved products, and the agency's decision means the approved versions of tirzepatide are considered sufficient to meet national demand ^[1].

FDA attributed reports of unfilled prescriptions to distribution between manufacturers, wholesalers and retailers rather than to a national shortage, and said some people may still encounter such problems ^[1]. The number of patients who were using compounded tirzepatide has not been disclosed in these documents, and it is not established how quickly individual pharmacies will stop supplying it.

Semaglutide, the ingredient in Ozempic, Wegovy and Rybelsus, is on a similar path with later dates. On February 21, 2025, FDA determined the semaglutide injection shortage was resolved ^[2].

What happens next

For semaglutide injection products, FDA does not intend to take action against state-licensed pharmacies or physicians compounding under section 503A until April 22, 2025, and against outsourcing facilities under section 503B until May 22, 2025, or until a district court decides a pending preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.), whichever is later ^[2].

The litigation over compounded GLP-1s remains ongoing, and Frier Levitt noted in January that pharmacies continue to report shortages ^[3]. As of February 21, 2025, FDA still listed dulaglutide injection and liraglutide injection as in shortage ^[2].